Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Modafinil
Drug ID BADD_D01484
Description Modafinil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA.
Indications and Usage To improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy.
Marketing Status approved; investigational
ATC Code N06BA07
DrugBank ID DB00745
KEGG ID D01832
MeSH ID D000077408
PubChem ID 4236
TTD Drug ID D07HQC
NDC Product Code 46438-0655; 63285-000; 63552-066; 70771-1051; 71205-477; 46438-0102; 65862-602; 60505-2526; 65862-601; 68071-2844; 69452-343; 65129-1102; 71205-544; 71335-1096; 63459-201; 68084-721; 70771-1052; 71335-1402; 72578-006; 63459-101; 23155-604; 71335-1793; 71610-685; 71335-1122; 72578-005; 50268-571; 55253-801; 57237-155; 60505-2527; 62332-385; 69452-342; 71335-1173; 0904-6423; 58175-0378; 63552-067; 23155-605; 46708-385; 55253-802; 63285-001; 46708-386; 63629-7315; 68084-621; 68788-7432; 68788-8280; 0904-6424; 0904-6791; 0904-6792; 72761-023; 42043-161; 50268-570; 57237-154; 62332-386; 63629-4998; 68788-8079; 63415-0036; 65862-576; 42043-160; 43353-925
UNII R3UK8X3U3D
Synonyms Modafinil | 2-((Diphenylmethyl)sulfinyl)acetamide | Vigil | Sparlon | Nuvigil | Alertec | Benzhydrylsulfinylacetamide | Armodafinil | 2-((R)-(Diphenylmethyl)sulfinyl)acetamide | R-Modafinil | R Modafinil | Provigil | Modiodal | CRL 40476 | CRL-40476
Chemical Information
Molecular Formula C15H15NO2S
CAS Registry Number 68693-11-8
SMILES C1=CC=C(C=C1)C(C2=CC=CC=C2)S(=O)CC(=O)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vertigo17.02.12.002; 04.04.01.0030.001111%
Viral infection11.05.04.001--Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.0030.003128%
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Mobility decreased17.02.05.018; 08.01.03.030; 15.03.05.023--Not Available
Multiple sclerosis relapse17.16.01.0030.000823%Not Available
Hypoacusis04.02.01.006--
Autoimmune thyroiditis10.04.08.006; 05.02.04.0020.000412%Not Available
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Central nervous system lesion17.02.10.011--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.0010.000412%Not Available
Haemorrhage24.07.01.0020.000412%Not Available
Urine odour abnormal20.02.01.0200.001399%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000412%
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Vasodilation procedure25.03.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Adverse event08.06.01.0100.000412%Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000412%Not Available
Gastrointestinal motility disorder07.02.03.0010.000412%Not Available
Mental disorder19.07.01.002--Not Available
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